An interventional study of Black Tea Extract and 0.5% Povidone Iodine Impregnated Sterile Gauze in Extracted Socket, sponsored by Manipal University College Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Manipal University College Malaysia · Not applicable, Interventional, and Treatment
Black tea is made from the leaves of a bush called Camellia sinensis. The main difference between green tea and black tea is that green tea is not completely oxidized while black tea is fully oxidized. Immediately after being harvested, the leaves of green tea are heated in order to halt the oxidation process, this ensures that the tea experiences minimal oxidation and stays a bright green color. Black tea, meanwhile, is allowed to fully oxidize after it is harvested. This means that the leaves turn brown or black, with green no longer present anywhere on the leaf. The chemical composition of black tea are tannins, theaflavins, carbohydrates, thearubigins, protein, flavonols, mineral matter, phenolic acids, volatiles, amino acids, methylxanthine. Among these, tannins play an important role in our research which helps in bleeding cessation after tooth extraction. Prolonged bleeding after tooth extraction can cause discomfort and thus affect patient's healthcare. Several methods have been proposed to enhance bleeding cessation, including the use of haemostatic agents and natural remedies such as tea. Black tea, in particular, has been suggested to have potential haemostatic properties due to its high content of tannins and flavonoids. However, the efficacy of black tea in promoting bleeding cessation after tooth extraction remains unclear. The purpose of this study is to evaluate the effect of black tea extract on primary bleeding cessation after extraction of molars. The study aims to investigate the potential benefits of black tea in reducing the bleeding time compared to a controlled group which uses normal sterile gauze. Our null hypothesis states that there is no difference in primary bleeding cessation time for black tea extract-impregnated sterile (BTE) gauze and 0.5% povidone iodine-impregnated sterile (PVI) gauze.
This study will be conducted in Oral Maxillofacial and Surgery Department in Polyclinic A, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-four randomly selected patients with molar extraction, satisfying the inclusion criteria and exclusion criteria stated. BTE gauze or PVI gauze will be placed at the freshly extracted socket after extraction. The state of bleeding of the socket is observed at 2,5 and 7 minutes.
Manipal University College Malaysia is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Other: Black Tea Extract
Other: 0.5% Povidone Iodine Impregnated Sterile Gauze
Sterile gauze is impregnated into 5ml of black tea-extract solution with tannin concentration 18.67mg/ml
Diluted povidone-iodine act as negative control is added into sterile gauze to color blind the involved subject and the operator
Evaluation of the Effect of Black Tea Extract-Impregnated Gauze on Primary Bleeding Cessation After Molar Extraction
A stopwatch is used by the investigator to check the bleeding status of the extracted socket at 2, 5 and 7 minutes after compression of the socket with black tea extract-impregnated gauze or color-blinded sterile gauze
Time frame: Primary bleeding cessation after extraction of molar is assessed up to 7 minutes
To Identify Adverse Effect of Black Tea-extract Impregnated Sterile Gauze and 0.5% Povidone Iodine Impregnated Sterile Gauze on Post-extraction Sites.
Evaluate the presence of adverse effect 3 days after extraction via phone
Time frame: 3 days post-extraction
| Milestone | 0.5% Povidone Iodine Impregnated Sterile Gauze | Black Tea-Extract Impregnated Sterile Gauze |
|---|---|---|
| Started | 22 | 22 |
| Completed | 22 | 22 |
| Not completed | 0 | 0 |
A stopwatch is used by the investigator to check the bleeding status of the extracted socket at 2, 5 and 7 minutes after compression of the socket with black tea extract-impregnated gauze or color-blinded sterile gauze
| Participants | 0.5% Povidone Iodine Impregnated Sterile Gauze | Black Tea-Extract Impregnated Sterile Gauze |
|---|---|---|
| less than 2 minutes | 17 | 12 |
| 2-5 minutes | 4 | 10 |
| 6-7 minutes | 1 | 0 |
Evaluate the presence of adverse effect 3 days after extraction via phone
| Participants | 0.5% Povidone Iodine Impregnated Sterile Gauze | Black Tea-Extract Impregnated Sterile Gauze |
|---|---|---|
| Not present | 22 | 22 |
| present | 0 | 0 |
Collected over 3 days post-extraction. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.5% Povidone Iodine Impregnated Sterile Gauze | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Black Tea-Extract Impregnated Sterile Gauze | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Customized(Participants) | 0.5% Povidone Iodine Impregnated Sterile Gauze | Black Tea-Extract Impregnated Sterile Gauze | Total |
|---|---|---|---|
| less than 21 years old | 1 | 5 | 6 |
| 21-30 | 1 | 3 | 4 |
| 31-40 | 2 | 3 | 5 |
| 41-50 | 6 | 2 | 8 |
| 51-60 | 6 | 4 | 10 |
| more than 60 years old | 6 | 5 | 11 |
| Sex: Female, Male(Participants) | 0.5% Povidone Iodine Impregnated Sterile Gauze | Black Tea-Extract Impregnated Sterile Gauze | Total |
|---|---|---|---|
| Female | 11 | 18 | 29 |
| Male | 11 | 4 | 15 |
| Race and Ethnicity Not Collected(Participants) | 0.5% Povidone Iodine Impregnated Sterile Gauze | Black Tea-Extract Impregnated Sterile Gauze | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Manipal University College Malaysia